CQI/IRCA CERTIFIED QMS LEAD AUDITOR TRAINING
This five day course provides the skills and knowledge that have taken many experienced auditors decades to develop. During the course, you will plan and prepare audits based on case studies that simulate both supplier and third-party audits utilizing the MDSAP audit requirements. You will participate in simulated auditing exercises that include planning, preparation and evaluation of audit evidence, all while practicing the application of ISO 13485:2016 and the MDSAP requirements.
510(K) PREMARKET NOTIFICATION WORKSHOP
This two day workshop is a one-stop shop to learn about the clearance process and compliant marketing of medical devices through the 510(k) program. This workshop provides a comprehensive overview of one of FDA’s primary premarket pathways.